Lambrolizumab for Advanced Melanoma
Merck has announced that the FDA has designated lambrolizumab
(MK-3475) as a Breakthrough Therapy for the treatment
of patients with advanced melanoma. Lambrolizumab is Merck’s
investigational antibody therapy targeting Programmed Death receptor
(PD-1) that is currently being evaluated for the treatment of
patients with advanced melanoma, and other tumor types.
The designation of an investigational drug as a Breakthrough
Therapy is intended to expedite the development and review
of a candidate that is planned for use, alone or in combination,
to treat a serious or life-threatening disease or condition
when preliminary clinical evidence indicates that the drug may
demonstrate substantial improvement over existing therapies
on one or more clinically significant endpoints.
Lambrolizumab is an investigational antibody therapy designed
to disrupt the action of the immune checkpoint protein PD-1 and
therefore inhibit the ability of some cancers to evade the body’s
immune system. Lambrolizumab is being studied in multiple cancer
types including melanoma and non-small cell lung cancer.
European Union and Erivedge
Roche has announced that the European Union’s Committee for
Medicinal Products for Human Use (CHMP) has recommended
conditional approval of Erivedge (vismodegib) for the treatment
of adult patients with symptomatic metastatic basal cell carcinoma,
or locally advanced basal cell carcinoma inappropriate
for surgery or radiotherapy. Conditional approval would make
Erivedge the first licensed treatment for patients in Europe with
these disfiguring, debilitating and even fatal forms of skin cancer,
which are known collectively as advanced basal cell carcinoma.
The CHMP stated, on the basis of quality, safety and efficacy
data submitted, considers there to be a favorable benefit-to-risk
balance for Erivedge and therefore recommended the granting
of the marketing authorization. This marketing authorization is
conditional, and will require the submission of additional data
from ongoing studies. The CHMP grants conditional approval to
medicinal products that fulfill an unmet medical need.
The conditional recommendation was based on findings from
the ERIVANCE BCC phase II study which enrolled 104 advanced
basal cell carcinoma patients (71 had locally advanced and 33
had metastatic disease) from 31 study sites in the US, Australia
and Europe. The study showed Erivedge substantially shrank
tumors or repaired visible lesions, as defined by objective response
rate, in 42.9 percent of patients with locally advanced and 30.3 percent of patients with metastatic basal cell carcinoma as assessed by independent review.
The most common adverse events included muscle spasms, hair
loss, altered taste sensation, fatigue and weight loss. Serious adverse
events (SAEs) were observed in 26 patients (25 percent),
however of these only four (4 percent) patients had SAEs that
were considered to be related to treatment with Erivedge. Fatal
events were reported in seven patients (7 percent) although none
were considered by investigators to be related to treatment with
Erivedge. In all cases, patients had other pre-existing diseases or
symptoms that were related to their presumed cause of death.
The safety profile of Erivedge is being further assessed in STEVIE,
a global, single-arm, open-label, multicentre study of patients with
advanced forms of basal cell carcinoma. The study aims to enroll
1,200 patients. An interim analysis from STEVIE confirmed a similar
safety profile to that observed in the ERIVANCE BCC study.
Erivedge is a Hedgehog pathway inhibitor, designed to selectively
target abnormal signaling in a cell growth pathway,
known as the Hedgehog signaling pathway. The Hedgehog
signaling pathway is implicated in the development of certain
types of cancer, including basal cell carcinoma.
The FDA approved Erivedge in 2012 under the priority review program
that provides for an expedited six-month review of drugs
that offer major advances in treatment, making it the first licensed
medicine for patients with advanced basal cell carcinoma.
FDA Approval for Topicort
Taro Pharmaceutical Industries Ltd. has reported that it received
approval from the FDA for its New Drug Application
Topicort®(desoximetasone) Topical Spray, 0.25%.
Topicort® (desoximetasone) Topical Spray, 0.25% is a corticosteroid
indicated for the treatment of plaque psoriasis in patients
18 years of age or older.
FDA Approves First Botulism Antitoxin
The FDA has announced that it has approved Botulism Antitoxin
Heptavalent (A, B, C, D, E, F, G)-(Equine) to treat patients
showing signs of botulism following documented or suspected
exposure to botulinum neurotoxin. The product is derived
from horse plasma and contains a mixture of antibody fragments
that neutralize all of the seven botulinum nerve toxin
serotypes known to cause botulism.
